Alternative approach to relative bioavailability and bioequivalence evaluation, with drugs following Michaelis-Menten elimination kinetics.
An alternative approach to bioavailability and bioequivalence assessment is presented. By a modified Wagner-Nelson procedure, the parameters of a monocompartmental model are calculated, after single oral dose administration trials. The usefulness of the procedure described here is that it permits comparison between two different brands of drug in multiple doses, without the need to administer repeated doses. Only one dose is necessary in order to calculate model parameters and infer steady-state levels.
Fagiolino
P
P
Laboratorio de Farmacodinamia, Facultad de Quimica, Montevideo, Uruguay.
Stareczek
S
S
D001682:Biological Availability; D006801:Humans; D008954:Models, Biological; D010599:Pharmacokinetics; D010672:Phenytoin / Q000097:blood / Q000493:pharmacokinetics; D012984:Software; D013810:Therapeutic Equivalency
D010672:Phenytoin